Clinical Trials/NCT06246565

NCT06246565

Not yet recruiting

Phase 2

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-designed Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of HS-10383 in Chinese Adult Subjects With Refractory or Unexplained Chronic Cough (RUCC)

Jiangsu Hansoh Pharmaceutical Co., Ltd.0 sites276 target enrollmentMarch 1, 2024

ConditionsCough

InterventionsHS-10383 HS-10383 Placebo

DrugsHS-10383 HS-10383 Placebo

Overview

Phase: Phase 2
Intervention: HS-10383
Conditions: Cough
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Enrollment: 276
Primary Endpoint: 24-Hour Cough Frequency
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-designed phase 2 clinical trial to evaluate the efficacy, safety and pharmacokinetic (PK) characteristics of HS-10383 in Chinese adult subjects with refractory or unexplained chronic cough (RUCC).

Detailed Description

The primary objectives of this study are to evaluate the efficacy of HS-10383 in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of HS-10383. The primary hypothesis is that at least one dose of HS-10383 is superior to placebo in reducing coughs per hour (over 24 hours) at Week 4.

Registry

clinicaltrials.gov

Start Date

March 1, 2024

End Date

June 1, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects should have a full understanding of the study contents, process, and possible adverse reactions, and voluntarily sign the informed consent form;
•Subjects aged 18-70 years (including the critical value) with RUCC ≥1 year (diagnosis of RUCC according to the Expert Consensus on Diagnosis and Treatment of Refractory Chronic Cough in China \[Released in 2021\]);
•Subjects whose serum pregnancy test is negative in both screening and baseline visits;

Exclusion Criteria

•Subjects who are diagnosed with chronic obstructive pulmonary disease, bronchiectasis, idiopathic pulmonary fibrosis and other serious lung diseases;
•Any physiological or mental disease or condition that may increase study risks or interfere with the conduct of the study or affect the ability to complete this study in the opinion of the investigator, such as medical history of depression;
•Subjects who cannot meet the requirements for piror treatment or who cannot adhere to the concomitant treatment as specified in Section 6.7-Prior/concomitant medications and non-drug treatment.
•Subjects with positive hepatitis A IgM antibody, hepatitis C antibody (HCVAb), syphilis antibody or human immunodeficiency virus (HIV) antibody at screening visit; subjects with positive hepatitis B surface antigen (HBsAg) at screening (except for quantitative detection result of HBV-DNA is below the lower limit of the detection reference range).
•Any former smoker with more than 20 packs/year; or have quited smoking for less than 6 months; or subjects who are still smoking (including e-cigarettes);
•Subjects who have a history of serious drug, food or environmental allergies, or who are known to be allergic to the ingredients of investigational product;
•History of drug dependence,drug or alcohol abuse in the past year;
•Female subjects who are pregnant or breastfeeding;
•Subjects who have previously received anything that may affect drug absorption, including but not limited to: gastrectomy, gastroplasty, any type of weight-loss surgery, vagotomy or enterotomy;
•Subjects who have been vaccinated within 30 days before screening visit, or have a vaccination plan during the whole study period.

Arms & Interventions

HS-10383 50mg

HS-10383 oral dose 50 mg once a day.

Intervention: HS-10383

HS-10383 100mg

HS-10383 oral dose 100 mg once a day.

Intervention: HS-10383

HS-10383 200ng

HS-10383 oral dose 200 mg once a day.

Intervention: HS-10383

Placebo

Matching Placebo for HS-10383 oral dose once a day

Intervention: HS-10383 Placebo

Outcomes

Primary Outcomes

24-Hour Cough Frequency

Time Frame: at Week 4

Assessed using an ambulatory cough monitor

Secondary Outcomes

Awake Cough Frequency(at Week 4)
Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 2 and Week 4.(at Week 2 and Week 4)
Change from Baseline in Cough Severity Visual Analogue Scale at Week 2 and Week 4;(at Week 2 and Week 4)